510(k) K924429 ยท JHY Colorimetric Method, Cpk Or Isoenzymes
OPUS(R) CK-MB
| Applicant | Pb Diagnostic Systems, Inc., Westwood MA, US |
| Decision | Substantially Equivalent, Oct 15, 1992 |
| Received | Sep 1, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K924429
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.